A Broad Outline of a Genus's Perimeter Is Insufficient For Written Description of the Members of the Genus

Attorney: Marina I. Miller, Ph.D.
April 7, 2023

The Regents of the University of Minnesota (“Minnesota”) appealed from a final decision of the U.S. PTO Patent Trial and Appeal Board (“the Board”) holding that the claims of U.S. Patent 8,815,830 were unpatentable as anticipated. The Court of Appeals for the Federal Circuit (“the Court”) affirmed.<... Read more

Federal Circuit Reiterates: Isolated Natural Products Alone Are Not Patent Eligible Without A Markedly Different Characteristic

March 3, 2023

co-authored by Sara Pistilli, PharmD. and Richard D. Kelly<... Read more

Reasonable Expectation of Success in Treating Different Conditions Not Implied by Structural Similarity

Attorney: Derek Lightner, Ph.D.
February 7, 2023

In the matter of Ex parte Taleb, et al., the Patent Trial and Appeal Board (PTAB) determined on January 31, 2023, that an examiner (James Anderson, supported by Supervisory Patent Examiners, Jeffrey Lundgren and Kortney Klinkel) failed to establish the obviousness of claims by failing to establish a reasonable expectation of success in achieving a claimed result of a method claim. The claim in question recited<... Read more

Written Description is Not Always Your Friend

Attorney: Richard D. Kelly
November 21, 2022

While an adequate written description is essential for patentability, 35 U.S.C. § 112(a), like everything else too much can have adverse consequences as uniQure biopharma recently learned in IPR2021-00926 (IPR) involving U.S.P. 9,982,248 (‘248).<... Read more

A Class of 957 Predicted Salts Is Insufficient To Meet the ‘At Once Envisage' Standard

Attorney: Marina I. Miller, Ph.D.
October 26, 2022

Mylan Pharmaceuticals, Inc. (“Mylan”) appealed from the final written decision of the USPTO Patent Trial and Appeal Board (the “Board”) holding that Mylan failed to show that claims 1–4, 17, 19, and 21–23 of U.S. Patent 7,326,708 (the “’708 patent”) were anticipated or would have been obvious over the cited prior art.<... Read more

Is the Supreme Court Poised to Consider the Federal Circuit's "Possession of the Invention" Definition of Written Description?

Attorney: Richard D. Kelly
October 5, 2022

The Supreme has relisted the petition for certiorari in Juno Therapeutics, Inc. v. Kite Pharma, Inc., 21-1566 where Juno petitioned for review of the Federal Circuit’s decision reported at 10 F.4th 1330 (2021) reversing the decision of the lower court finding U.S.P. 7,446,190 to not be invalid for lack of written description or enablement and awarding damages of over $1.2 billion. While the relisting of a certiorari petition does not guarantee cert will be granted, statically since 2016 between about 30 and 40% of relisted petitions have been granted. The SCOTUS blog has detailed analysis here. Considering that the overall grant rate for petitions is only about 4% this indicates that the Juno petition has a much greater than normal possibility of being granted.<... Read more

Federal Circuit Trumped By Supreme Court On Stay Of Mandate In Gilenya

Attorney: Richard D. Kelly
October 3, 2022

Just two days after the Federal Circuit denied a stay of its mandate in Novartis v. HEC Pharm Co., Ltd., the Supreme Court granted a stay of the mandate pending a further order of the Court and requiring HEC to file a response to the Novartis stay request.<... Read more

Product-by-Process Claim: The Focus is On the Product and Not the Process of Making It

Attorney: Marina I. Miller, Ph.D.
September 6, 2022

Kamstrup A/S appealed a final written decision of the Patent Trial and Appeal Board (“the Board”). The Board found claims 1–15 of Kamstrup’s U.S. Patent No. 8,806,957 unpatentable as obvious or anticipated. On appeal, Kamstrup challenged the Board’s claim constructions. In addition, Kamstrup challenged the Board’s anticipation and obviousness determinations largely on the basis that the Board erred in rejecting Kamstrup’s claim construction arguments.<... Read more

Bio/Pharma IPRs: Will Institution Rates Rise in Response to USPTO Initiatives?

Attorney: Richard D. Kelly
August 12, 2022

When it comes to IPR petitions filed in the Bio/Pharma space, USPTO data tells us that while Bio/Pharma petitions make up only 8% of the total petitions filed for the fiscal year of 2022 (through June 30, 2022), there is a high intuition rate for those Bio/Pharma petitions. According to USPTO statistics, 80% of the Bio/Pharma cases have been instituted so far this year.  Put differently, 59 of the 74 petitions reviewed were subsequently granted.<... Read more

Teva Files Certiorari Petition in "Skinny" Label Case

Attorney: Richard D. Kelly
August 9, 2022

On July 11, Teva filed its petition for certiorari from the Federal Circuit’s second decision in its “skinny label” litigation with GSK, 7 F.4th 1320 (Fed, Cir. 2022). The petition makes many of the same arguments that Teva made before the Federal Circuit but the inconsistency of the Federal Circuit’s decision in GSK with three prior decisions standout. Its yet another example of the Federal Circuit’s lack of discipline in following its own precedent. While Teva rightly complains that the decision creates uncertainty around the skinny label provisions of 21 U.S.C. § 355(j)(2)(A)(viii), the real uncertainty is created by the Federal Circuit’s unfortunate habit of ignoring its own precedent upon which parties rely in making decisions.<... Read more